Z-2039-2021 Class II Terminated
FDA device recall Z-2039-2021 was initiated by BioFire Diagnostics, LLC on June 7, 2021 and is designated Class II. Reason for recall: Due to real-time stability study failures resulting in increase rate of false negative results between the 6 to 12 month expiry time-frame. The recall status is terminated (terminated July 31, 2023). Affected quantity: 4,462 kits (Globally).
Recall Details
- Product Type
- Devices
- Report Date
- July 14, 2021
- Initiation Date
- June 7, 2021
- Termination Date
- July 31, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,462 kits (Globally)
Product Description
Reason for Recall
Distribution Pattern
U.S.: AK, AL, AZ, CA, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, IN, KS, KY, KY, LA, MA, MD, ME, MI, MI, MN, MO, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, TN, TX, UT, VA, VT, WA, WI, WV and WY. O.U.S.: Algeria, Angola, Anguilla, Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bermuda, Bolivia, Bosnia-Herz., Brazil, Bulgaria, Chile, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, France, Georgia, Germany, Greece , Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latvia, Lebanon, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Myanmar, Nepal, Netherlands, Nicaragua, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Kingdom, Uruguay, United Arab Emirates, and Vietnam.